Getting Out of the House: A Behavioral Activation Approach to Support Community Participation With Individuals With Serious Mental Illness
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Behavior Activation for Depression Scale
研究概览
简要总结
The goal of this study is to evaluate the effectiveness of an behavioral activation intervention to increase meaningful activity and community participation for people with serious mental illness.
The overall objective of this study is to increase engagement in meaningful activities and community participation. The objectives of the project are as follows:
- To determine if the intervention leads to increases the frequency and variety of activities.
- To determine if the intervention leads to increases in community mobility.
- To determine which demographic and environmental factors and mechanisms of action impact the effectiveness of the intervention.
- To determine if the the intervention leads to an improvement in overall well-being (e.g., improved quality of life).
Participants will be asked to attend a 2-hour weekly online session for 10 weeks and then a 1-hour online monthly session for a 3 month maintenance period.
For data collection, participants will also be asked to:
- Complete three, approximately 1-hour interviews at baseline, after the 10 week intervention, and again at the end of the maintenance period;
- Carry a mobile phone with a global positioning system app to track their movements outside their home for 2 weeks at a time, at three separate times (e.g., baseline, after the intervention, and at the end of the maintenance period); and
- Complete a 15 minute weekly interviews for 26 weeks about their daily activities and participation.
The study will enroll 52 participants split into 4 cohorts of 13. The study will use a multiple baseline design and, as such, all participants will receive the intervention and there is no control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •must respond yes to three questions related to their history with serious mental illness (see below);
- •a score of 8 or higher on the Center for Epidemiologic Studies Depression Scale - Revised -10 (CES-D-R-10)
- •have Internet access;
- •be willing to carry a cell phone with a GPS tracking application;
- •indicate that they would like to participate more in the community;
- •be able to communicate in English;
- •be over the age of 18; and
- •and be available on for the day and time (i.e., Monday, Tuesday, Wednesday, Thursday, or Friday) the intervention is scheduled for each cohort.
- •Questions related to history with serious mental illness:
- •"Have you ever been told by a psychiatrist or other mental health professional that you have major depression, bipolar disorder, manic depression, schizophrenia or schizoaffective disorder?",
- •"Have you ever been hospitalized for this mental health or emotional problem?", and
- •"Has this mental health or emotional problem substantially interfered with or limited your ability to participate in any major life activities such as work, school, recreation, social activities, religious activities, family relationships, or caring for yourself?" Answering yes to these 3 questions would be indicative of a lifetime serious mental illness.
排除标准
- •those who are unable to give informed consent
- •those who report having a legal guardian -
研究组 & 干预措施
Intervention group
All participants will receive an online behavioral intervention for 10 weeks, followed by monthly maintenance sessions for 3 months.
干预措施: Behavior Activation (Behavioral)
结局指标
主要结局
Behavior Activation for Depression Scale
时间窗: administered 26 times: 1 time per week for 26 weeks
The behavior activation depression scale measures related to activity, social interaction, and negative thinking or feelings There are 25 statements measured on a 6-point Likert scale varying from not at all to completely. The range of scores is 0 to 54, with high scores representing higher behavioral activation.activities
Community Mobility (Global Positioning System; GPS)
时间窗: administered 3 times for 2 weeks: at baseline, within 1 month following the 10 weeks of weekly meetings, and 3 months later within 1 month following the end of the intervention
Participants will carry a cellphone that will track their movements in the community using a GPS app. GPS data shows movements in the community in distance traveled in kilometers. This will be analyzed as total distance traveled.
Temple University Community Participation Measure
时间窗: administered 3 times: at baseline, within 1 month following the 10 weeks of weekly meetings, and 3 months later within 1 month following the intervention
Measures engagement in 29 participation areas, if those areas are important to them, how often they did them and if it was enough, not enough, or too much. Higher reported frequency across a greater number of areas indicates higher rates of participation. Higher number of activities reported as being important and done enough indicate greater sufficiency of participation.
Activity Logs
时间窗: administered 26 times: 1 time per week for 26 weeks.
The activity logs are open ended forms in which participants are asked to enter in the primary activities they did in a day (e.g., work), the amount of time they did if for (e.g., 2 hours), how effortful it was on a scale of 1-5, and what their mood was before, during, and after the activity on a scale of 1-5. A higher score on effort (5) is indicative of greater effort, and a higher score ono mood indicates a better or more positive mood. Activities type will be analyzed qualitatively.
Participation Checklist
时间窗: administered 26 times: 1 time per week for 26 weeks
Participants will be asked to state whether they did an activity from a list of 20 items. Response options include yes or no. A greater number of "yes" responses will indicate a greater level of participation that week.
次要结局
- Lerman Quality of Life Interview(administered 3 times: at baseline, within 1 month following 10 week intervention, and within 1 month following the maintenance period 3 months later)
- New General Self-Efficacy Scale (adapted to participation)(administered 3 times: at baseline, within 1 month following the 10 week intervention, and within 1 month following the maintenance period 3 months later)
- Self-Control and Self-Management Scale(administered 3 times: at baseline, within 1 month following the 10 week intervention, and within 1 month following the maintenance period 3 months later)
- University of California Los Angeles Loneliness Scale(administered 3 times: at baseline, within 1 month following the 10 week intervention, and within 1 month following the maintenance period 3 months later)
- Recovery Assessment Scale (RAS)(administered 3 times: at baseline, within 1 month following the 10 week intervention, and within 1 month following the maintenance period 3 months later)
- Activity Assessment Scale(administered 3 times: at baseline, within 1 month following 10 week intervention, and within 1 month following the maintenance period 3 months later)
- Habit Strength Scale(administered 3 times: at baseline, within 1 month following the 10 week intervention, and within 1 month following the maintenance period 3 months later)
- Reward Probability Index(administered 3 times: at baseline, within 1 month following the 10 week intervention, and within 1 month following the maintenance period 3 months later)
- Capabilities and Opportunities for Participation Questionnaire(administered 3 times: at baseline, within 1 month following the 10 week intervention, and within 1 month following the maintenance period 3 months later)
- The Life Engagement Test(administered 3 times: at baseline, within 1 month following the 10 week intervention, and within 1 month following the maintenance period 3 months later)
- The University of Rhode Island Change Assessment Measure (URICA)(administered 3 times: at baseline, within 1 month following the 10 week intervention, and within 1 month following the maintenance period 3 months later)
- Lehman Quality of LIfe (QOL) Interview Social Relations sub scale(administered 3 times: at baseline, within 1 month following the 10 week intervention, and within 1 month following the maintenance period 3 months later)
- Hopkins Symptoms Checklist(administered 3 times: at baseline, within 1 month following the 10 week intervention, and within 1 month following the maintenance period 3 months later)